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Epilepsy clinical trials

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NCT ID: NCT01546688 Terminated - Epilepsy Clinical Trials

A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

Start date: November 2008
Phase: Phase 4
Study type: Interventional

A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).

NCT ID: NCT01545518 Terminated - Seizure Disorder Clinical Trials

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG). The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG. At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

NCT ID: NCT01529034 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

NCT ID: NCT01501383 Terminated - Epilepsy Clinical Trials

A Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial Epilepsy

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in subjects with treatment-resistant partial epilepsy.

NCT ID: NCT01496612 Terminated - Depression Clinical Trials

Buspirone Therapy for Localized Epilepsy

Start date: November 22, 2011
Phase: Phase 2
Study type: Interventional

Background: Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication. Objectives: To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain. Eligibility: Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain. Participants must have tried at least two different antiseizure medications. Participants must also have had at least three seizures during a 1-month observation period while on current medicines. Design: Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected. Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone. Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks. After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone. Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.

NCT ID: NCT01494584 Terminated - Epilepsy Clinical Trials

Study in Pediatric Subjects With Epilepsy

Start date: July 25, 2012
Phase: Phase 2
Study type: Interventional

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.

NCT ID: NCT01462656 Terminated - Epilepsy Clinical Trials

Risk of Urinary Retention With Retigabine

Start date: February 2011
Phase: N/A
Study type: Observational

A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed until the earliest of an episode of urinary retention (UR), change in their AED regimen, end of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users has been attained). After the end of study, the incidence of UR during exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen containing at least two different AEDs. A prospective cohort study of patients who receive EZG under circumstances not indicated in the product label within the HIRD will also be conducted. Following the launch of EZG, epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients initiating EZG for another disease will be followed until the earliest of an episode of UR, change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence of UR during exposure to EZG under circumstances not indicated in the product label will be described. A descriptive analysis of the patients will also be included. To meet the other secondary objective, non-EZG AED monotherapy users will be identified in the prospective cohort and incidence of UR will be calculated to determine if there is a difference in UR risk between monotherapy and polytherapy AED use.

NCT ID: NCT01390220 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters

ARTEMIS1
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

NCT ID: NCT01363154 Terminated - Epilepsy Clinical Trials

Prevention of Photoparoxysmal Abnormalities by Mozart K448

Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.

NCT ID: NCT01316445 Terminated - Epilepsy Clinical Trials

Pharmacodynamics of Nasal and Buccal Midazolam Using EEG

nMDZ-EEG
Start date: July 2011
Phase: Phase 1
Study type: Interventional

Approximately 3 million individuals suffer from epilepsy in America alone and about 200,000 new cases of epilepsy in America are diagnosed each year (Epilepsy Foundation, 2005). Epilepsy can be defined as a condition in which a person has recurrent, unprovoked seizures. Prolonged or back-to-back repetitive seizures, known as "acute repetitive seizures" (ARS), are medical emergencies. ARS can occur unexpectedly, a circumstance for which quick and efficient antiepileptic drugs are needed for household and prehospital use. Currently, benzodiazepines are the antiepileptic drug of choice when dealing with ARS because they are proven to be efficient and take little time to work. Benzodiazepines can be administered by mouth, by vein via a needle (intravenously; IV), rectally, between the cheek and gum (buccally), or in the nose (intranasally; IN). The nasal formulation is not yet FDA-approved. The rectal treatment route has been commonly used for acute seizure treatment in past years, but recent studies propose that the nasal route for benzodiazepines may be better overall for home treatment and easier to administer (see Wermeling, 2009). For many "out of hospital" situations, nasal benzodiazepines can be more convenient and more comfortable than rectal treatment. In addition to the above benefits, nasal benzodiazepines are rapidly absorbed by the blood vessels in the nose and the time of drug administration and cessation of seizures may thus be reduced using nasal routes. This study sets out to characterize how fast buccal and nasal treatments begin to work on the brain by monitoring brain waves during administration of the drug, and to determine whether nasal or buccal administration is best.